Bristol-Myers Squibb sent the following statement to the Business & Human Rights Resource Centre in response to the report by the Interfaith Center on Corporate Responsibility, "Benchmarking AIDS: Evaluating pharmaceutical company responses to the public health crisis in emerging markets", available at: A PowerPoint presentation on the report is available at:

Bristol-Myers SquibbGlobal Access Program

12 September 2006

The goal of the Bristol-Myers Squibb Global Access program is to enable broad access to our HIV medicines at no-profit prices in the regions most impacted by HIV and with limited ability to pay. The Global Access encompasses our pricing policy, our patent policy, and our initiatives to enable generic manufacturer participation.

Patent Policy

Since 2001, Bristol-Myers Squibb has maintained a policy of not enforcing its patents for HIV products in sub-Saharan Africa. The company is committed to ensuring that its patents do not prevent inexpensive HIV/AIDS therapy in sub-Saharan Africa.

In May 2004, BMS granted a request from Thembalami Pharmaceuticals, a South African generics manufacturer, for immunity from suit to produce generic versions of stavudine and didanosine in sub-Saharan Africa. The company offered similar immunity from suit agreements in sub-Saharan Africa for stavudine and didanosine to Aspen Pharmacare, Afrika Biopharma Investments (Pty) Ltd, Adcock-Ingram and Aurobindo Pharma (Pty) Limited. Other immunity from suit agreements are currently in process.

Enabling Generic Companies

In order to ensure sustainable access to care for millions of HIV positive patients in sub-Saharan Africa, Bristol-Myers Squibb believes that generic manufacturers have a critical role to play. In 2004 Bristol-Myers Squibb agreed to allow the FDA to make right of reference to our confidential dossiers and product registration files in order to facilitate the approval of generic combination products under the PEPFAR program. In February 2006, Bristol-Myers Squibb announced a highly innovative agreement for full technology transfer of its newest antiretroviral, atazanavir, to two generic companies, Aspen and Emcure.

The tech transfer agreement seeks to expand access to atazanavir for people living with HIV/AIDS in sub-Saharan Africaand Indiaby ensuring access to a high quality product supported by local expertise, supply and infrastructure. It builds on BMS’ consistent leadership and long-term commitment to expand access to medicines in sub Saharan Africa and countries where HIV has reached epidemic levels.

Our tech transfer initiative extends beyond a voluntary license for these two generic companies to make our patented products for use against HIV. We are also providing know-how, training and appropriate regulatory support from our own in-house experts to facilitate the process of product registration, quality manufacture and availability. Through this agreement, the company is proactively engaging generic companies in order to secure multiple sources of supply for HIV medicines which will be greatly needed in treating millions of people living with HIV in sub-Saharan Africa.

Pediatric Formulations & Pricing

Bristol-Myers Squibb currently produces pediatric formulations of Videx® (didanosine), Zerit® (stavudine) and Sustiva® (efavirenz) (although the company does not own the rights to SUSTIVA in Africa).In addition we are actively working on establishing appropriate dosing for Reyataz® (atazanavir) in infants and children.

Since 2001, Bristol-Myers Squibb has sold our pediatric HIV formulations at a price which reflects no profit to the company. in July 2005 we announced the further reduction in the price of pediatric formulations from no-profit to significantly below cost in an attempt to further reduce barriers delaying broad and accelerated access to treatment for the millions of children in sub-Saharan Africa who need them most.

We fully the importance of urgently treating children infected with HIV/AIDS and are committed to increasing access to AIDS medicines by working with other stakeholders and through partnership initiatives such as AAI and PEPFAR's Public-Private Partnership for Pediatric AIDS Treatment. As we begin to address the critically important issues of support and infrastructure through ourSecure the Future initiative, we hope that many more children will have access to HIV treatment.
OVERVIEW OF SECURE THE FUTURE®

Care and Support for Women and Children with HIV/AIDS

Origin and Purpose

SECURE THE FUTURE is an innovative, comprehensive public-private initiative to help alleviate the HIV/AIDS crisis among women and children in sub-Saharan Africa, where 25 million people are infected with the disease. Bristol-Myers Squibb and the Bristol-Myers Squibb Foundation launched the initiative in 1999.

The goal of the program is to prevent HIV/AIDS and STD transmission, reduce the impact of HIV/AIDS, and expand access to treatment by informing public health policy. SECURE THE FUTURE was the first and remains the largest single corporate commitment of its kind to fight HIV/AIDS in Africa.

The range of SECURE THE FUTURE programs includes:

  • establishing six model community-based treatment centers that integrate community support with medical care in very resource limited settings;
  • funding approximately 90 medical studies and 100 community outreach and education programs;
  • building five clinical centers of excellence to treat HIV-infected children, three of which are now in operation Two more are under construction.
  • creating and supporting a pediatric AIDS corps to bring doctors to Africa to treat children, train local staff and extend the reach of the children’s centers to rural areas;
  • funding education and training programs for physicians, nurses and other public health professionals as well as NGO leaders;
  • supporting innovative public education programs for teens and entire communities; and
  • creating support programs for grandmothers and other caregivers – including nutritional and income-generating projects – and support services for orphans and vulnerable children.

Key Programs and Accomplishments

  • Community-Based Treatment Support Program – Pilot centers established in South Africa, Botswana, Swaziland, Lesotho, Namibia and Mali have demonstrated that comprehensive medical treatment and care combined with broad-based community support can be successful in fighting the disease in remote, poverty-stricken areas where health care and other resources are limited. Data from the centers prove for the first time the added value of community services in achieving better patient outcomes. Of more than 11,000 HIV-positive patients enrolled at these centers, 5,000 are on antiretrovirals (ARVs), and adherence rates are over 80%. Plans are under way to open similar programs elsewhere in southern and West Africa.
  • Children’s HIV/AIDS Clinical Centers of Excellence - SECURE THE FUTURE funded the construction and equipping of clinical centers in Botswana, Lesotho and Swaziland, operated by the Baylor International Pediatric AIDS Initiative with the assistance of host government funding. Centers in Burkina Faso and Uganda, also funded by the initiative, are scheduled to open in 2007. The centers provide multidisciplinary care for children and their families, state-of-the-art infrastructure and education and training for medical professionals.
  • Pediatric AIDS Corps - SECURE THE FUTURE and Baylor College of Medicine have created a program to send up to 250 pediatricians and family practitioners to Africa over five years – 50 doctors per year – to treat approximately 80,000 children and train local health care professionals. Seven pediatricians are already serving in Africa and additional members of the first wave of 50 doctors are scheduled to begin work in August 2006. The doctors are to be assigned to the countries that have children’s clinical centers.
  • BMS Foundation NGO Training Institute – This capacity-building program develops and builds organizational and individual skills for the delivery of support and care among non-governmental organizations (NGOs) and community-based organizations (CBOs) working with HIV/AIDS. The Institute creates model training modules and best practices in management, good governance and leadership. The program – the first of its kind in Africa – is currently in operation in South Africa, Botswana, Namibia, Lesotho and Swaziland. We are in ongoing discussions with PEPFAR to expand the program in Africa.
  • HIV/AIDS Model Curriculum for Health Care Workers – The initiative supported development of the Baylor College of Nursing’s model curriculum on HIV/AIDS and the Health Professional, now in its third edition. The curriculum has been adopted in 51 countries and endorsed by UNAIDS.
  • Public Health Masters Degree Program at the MedicalUniversity of Southern Africa – The initiative funded a distance learning public health training program providing a one-year diploma or Masters Degree program that has educated more than 260 professionals, 40% from the ministries of health.
  • HIV Reference Laboratory in Botswana - SECURE THE FUTURE co-funded establishment of the first HIV/AIDS Reference Laboratory in Botswana, operated by the Botswana-Harvard Partnership.
  • CD4-Count Test - SECURE THE FUTURE grantee Dr. Debbie Glencross developed a fast, affordable test for CD4-count that has been recognized by the WHO, adopted by the South Africa National Health Laboratory Service and approved by the U.S. FDA. This test is important because the cost of monitoring had long been a barrier to treatment in Africa.
  • Landmark Prevention of Mother To Child Transmission (PMTCT) Study – The initiative funded a clinical study that demonstrated that mother-to-child transmission of HIV – from positive mothers who did not access PMTCT medication prior to delivery – can be reduced through post-natal prophylactic antiretroviral (ARV) therapy. Dr. Glenda Gray and colleagues received the Nelson Mandela Award for Health and Human Rights for this accomplishment. Their findings have implications for PMTCT interventions in resource-limited settings.
  • In conjunction with the 65 clinical studies funded by SECURE THE FUTURE, many of which are still under way, more than 600 grantees have been trained in Good Clinical Practices by Bristol-Myers Squibb staff.

The commitment by Bristol-Myers Squibb through SECURE THE FUTURE has grown to $150 million, provided through more than 200 grants for innovative, cost-effective model programs. These programs support people living with HIV in clinics and at home; build medical capacity and infrastructure; and encourage development of sustainable programs that can be replicated elsewhere in Africa and in other parts of the world. The initiative started in five countries in southern Africa and was subsequently extended to West Africa and Central Africa. It now serves people in South Africa, Swaziland, Botswana, Namibia, Lesotho, Malawi, Senegal, Burkina Faso, Mali, Cote d’Ivoire and Uganda.

SECURE THE FUTURE has developed and funded innovative programs by creating a unique series of partnerships with government leaders, Ministries of Health, medical institutions in Africa and the U.S., physicians and other health care professionals, non-governmental, community-based and faith-based organizations, and people living with HIV/AIDS. Programs were recommended by independent local Technical Advisory Committees with full participation by personnel from national governments. They were aligned with national AIDS plans, developed with sensitivity to local traditions and customs, and designed to meet best-practice standards and demonstrate outcomes and impact.

To further extend the impact of SECURE THE FUTURE, the company is developing a guide for establishing medical treatment and community programs in resource-limited settings.